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Hamilton, Bermuda, July 14, 2021 – Auris Medical Holding Ltd. (NASDAQ:EARS), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, today announced additional preclinical data in a model of primary human nasal airway epithelium from its Bentrio™ (AM-301) nasal spray development program in SARS-CoV-2. AM-301 was found to be safe in vitro, and it significantly decelerated viral titer growth in experimental models of prophylaxis and mitigation. The manuscript describing these preclinical data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2021.07.12.452021v1 and will undergo scientific peer-review for potential publication.
"These data provide strong evidence for Bentrio's potential to help reduce the risk of SARS-CoV-2 infection of human mucosal cells when used preventatively and to decelerate its course when used shortly after its onset", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Recently published clinical data from an independent research group show that targeting the nasal mucosa during the early stage of Covid-19 is an ideal strategy for preventing the propagation of SARS-CoV-2.1 We look forward to the imminent start of the market roll-out of our Bentrio nasal spray to help address this current pandemic with a novel drug-free means for self-protection."
The preclinical studies were performed in a well-established model of reconstituted nasal epithelium from human donors (MucilAir™), which provides testing conditions that tend to be more challenging than real-life conditions in the human nose. AM-301 was studied to determine its compatibility with MucilAir™, its efficacy in preventing MucilAir™ from being infected by SARS-CoV-2, and its ability to mitigate an established infection in MucilAir™ without any previous treatment. First, AM-301 had no detrimental effects on MucilAir™ inserts despite repeated application over 4 days: measures of tight junction integrity and cytotoxicity support Bentrio's safety and did not show any significant difference between treated and control cultures. An expected finding was that the ciliary beat frequency was slightly reduced due to the viscosity of the formulation.
Prophylactic treatment with AM-301 was protective against SARS-CoV-2 infection, as daily application of the product starting 10 minutes prior to inoculation led to a 2-log (99%) reduction in viral titer (Tissue Culture Infectious Dose; TCID50) by Day 4 compared to controls. Inserts that received the product daily, starting 24 or 30 h after viral infection, also had a lower viral titer, corresponding to a 12- or 14-fold lower TCID50 at the end of the treatment. In a linear-effects mixed model with log-transformed data, the time profile of SARS-CoV-2 infection was significantly decelerated compared to controls both in case of prophylactic treatment (t=5.49; p<0.001) and in case of mitigation treatment starting 24 or 30 h post infection (t=3.68; p<0.01).
As recently announced, Auris Medical's affiliate Altamira Medica Ltd. will start the market roll-out of Bentrio™ by launching it in Germany. Bentrio™ will shortly become available through selected online pharmacies; over the coming months, market coverage will be expanded progressively through additional distribution channels and in further countries.
Posted In: EARS
